The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures (ARCTIC CAT)
Consenting patients with proximal tibia fractures will be randomized to 10 degree or 21 degree cryotherapy sleeves. Time to discharge and complications will be monitored.
Primary outcome measure: Cost of Treatment (based on length of stay) Secondary outcome measures: Satisfaction/pain relief and narcotic requirement
|Proximal Tibia Fracture||Device: Cryotherapy Device: Room temperature cuff||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||The Efficacy and Cost Effectiveness of Preoperative and Postoperative Cryotherapy in Proximal Tibia Fractures|
- Cost [ Time Frame: 3 months ]
- VAS Pain Score [ Time Frame: 2 weeks ]
- Narcotic Requirements [ Time Frame: 2 weeks ]
|Study Start Date:||April 2010|
|Study Completion Date:||November 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Placebo Comparator: 21 degree Cooling
Room temperature water circulated through cryotherapy sleeve.
Device: Room temperature cuff
sleeve with room temperature water placed over fracture site.
Active Comparator: 10 degree cooling
Cooled water circulated through a cryotherapy sleeve.
cooled sleeve placed over fracture site.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01104831
|Winnipeg Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|Principal Investigator:||Jesse A Shantz, MD, MBA||University of Manitoba|